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Model Number 777000 |
Device Problems
Defective Component (2292); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The evaluation determined the device core of the transformer on the pkrf board was broken causing low output.During testing, the unit was found to have a faulty auxiliary board.In addition, multiple scratches were observed on the top case.The key pad membrane was determined to have multiple scratches and a hole puncture.The software version required upgrade.Review of data log revealed no error(s) observed.The identified parts were replaced and device was repaired.The software version was upgraded.Once completed, the device was tested and passed required testing, and specifications.The reported failure was found to be electrical component failures of the pkrf board and the auxiliary board.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.
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Event Description
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It was reported that during an asset return inspection, the device was observed with a broken transformer core and with low output.There was no patient involvement on this reported event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The following sections were updated: g4, g7, h2, h4, h6, and h10.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.
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Search Alerts/Recalls
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